Making It In NM: TC lab doing its part to fight coronavirus

The 60 employees at Traverse City-based American Proficiency Institute are battling the coronavirus pandemic on three fronts: lab performance, finding a test and detecting antibodies. The institute’s clinical proficiency testing programs are approved by the federal Centers for Medicare & Medicaid Services (CMS), The Joint Commission healthcare accreditation service and all state health departments.

Maintain Lab Performance

API routinely tests the ability of some 20,000 U.S. medical labs to analyze blood samples and accurately confirm (or refute) the presence of any of the 300-plus medical conditions on a list that includes everything from pregnancy to cancer.

“We assure that the quality of lab work done nationwide is very high. And that helps assure public health,” said API president Dan Edson.

This month and again in early June API is sending these labs (located in hospitals, clinics and doctors’ practices) what Edson describes as “safe, simulated, non-infectious, 1.5 milliliter liquid samples.” In this case, some, but not all, of those samples should test positive for the coronavirus.

Find a Test

Arguably of equal importance is the hunt for a reliable, quick and widely available means of determining who has the virus. As of mid-April, less than 1% of all Americans had been tested for the coronavirus. Physicians, epidemiologists and governors complain this has hamstrung a proactive response.

So while it continues to maintain lab proficiency, API will also collect valuable data on the real-world performance of more than 30 coronavirus testing products now on the market. (That is possible because participating labs will indicate which brand of test they used.) API will then share those findings with its client labs, CMS and state health officials across the country. Edson also intends to publish results in a peer-reviewed medical journal.

API does not determine the “winner” (or winners) in the race for a quick, trustworthy coronavirus test. “We are impartial in our reporting – we take no sides,” he says. “We let the data speak.”

Detect Antibodies: The Next Big Hurdle

API’s role doesn’t end there, however. Later this summer, Edson will rely on data from the same 20,000 labs to measure the performance of various antibody testing methodologies. Knowing who has the right virus-fighting antibodies can lead to more targeted use of a vaccine, once one is on the market.

Edson says antibody testing “is complicated and not what a lot of people think it is.”

“A good antibody test like the one I developed for Legionnaires’ disease indicates who, through previous exposure, has built up defenses against the virus. By process of elimination, that means you can identify who needs immunization,” he said.

Once exposure rates are identified, resources can be targeted, Edson said.

“Antibody testing also gives you exposure rates by age, location and other epidemiological factors,” he said. “That knowledge helps in targeting resources once scientists have a cure.”
One thing API will not be involved in is vaccine testing.

“Vaccine trials are a whole different part of molecular biology,” Edson said. “Other companies concentrate on that.”